Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle— 510(k) K232950

Name: FDA 510(k) clearance K232950
Creator: U.S. Food and Drug Administration
Published: 2024-06-12

Substantially Equivalent

Perfect Medical Industry (Vn) Co., Ltd.

FDA 510(k) clearance K232950 for Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle, Substantially Equivalent on 2024-06-12. Applicant: Perfect Medical Industry (Vn) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Perfect Medical Industry (Vn) Co., Ltd.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2023-09-20
Decision date: 2024-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ho Chi Minh City, VN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMF

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K262581 — GraftGun Universal Graft Delivery System (GDS®)2026-08-26
K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray2026-08-25
K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)2026-08-14
K260208 — Ultra-Fine SAFETY Insulin Syringe2026-07-13
K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe2026-06-18

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.